Tosoh AIA-900 Analyzer Recalled for Substrate Monitoring Defect
Tosoh Bioscience Inc is recalling 529 AIA-900 Analyzers because the substrate monitoring system may fail to detect empty bottles, leading to erroneous immunoassay test results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves erroneous test results which could lead to incorrect medical decisions, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Tosoh Bioscience Inc is recalling 529 units of the AIA-900 Analyzer (Part no. 022930, UDI 04560189283992). The recall is due to a defect in the Substrate Monitoring System, which did not detect an empty substrate bottle. This issue may lead to erroneous immunoassay test results.
The affected devices were distributed domestically nationwide and internationally to Chile, Costa Rica, Cayman Islands, Dominican Republic, Ecuador, Guatemala, Honduras, Peru, Republic of Panama, El Salvador, and Uruguay. The recall covers specific serial numbers listed in the agency's documentation, ranging from 10030810 to 11479302.
Healthcare facilities and users should check their AIA-900 Analyzer serial numbers against the provided list. If a device is affected, users should contact Tosoh Bioscience Inc for instructions on corrective action. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- AIA-900 Analyzer, Part no. 022930, UDI 04560189283992
- Manufacturer
- Tosoh Bioscience Inc
- Affected units
- 529
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- From customer letter: Serial numbers 10030810
- 10101008
- 10142204
- 10212411
- 10253902
Distribution
Distributed nationwide across the United States.
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